Regulatory Approval & Compliance
ThinkSono Guidance is currently not FDA/CE IIb marked for clinical use. Please contact ThinkSono using the information below.
The current expected CE IIb intended use (not yet approved) will be:
“ThinkSono Guidance is a medical device software consisting of ThinkSono Guidance Mobile App and Cloud-based Software.
ThinkSono Guidance is a data collection and communication tool that guides non-ultrasound trained healthcare staff to collect point of care compression ultrasound data in the proximal deep venous system of the lower extremity for interpretation by qualified clinicians. ThinkSono Guidance produces DVT ultrasound data of at least minimal standard for diagnostic image quality.”
Please contact email@example.com for more information on the appropriate use of ThinkSono Guidance.